Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Friday, October 13, 2006

"Ghosts in the Machine"

We have posted several times (most recently here, with links backward) about the story of Dr Aubrey Blumsohn's dispute with Proctor and Gamble (P&G) and Sheffield University in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him, and he eventually lost his position there.

Dr Blumsohn just wrote a brilliant essay on the integrity of clinical research for the Professional Ethics Report published by the American Association for the Advancement of Science. I will quote from his introduction and then his conclusions. (In the center of his essay is a clear discussion of his case, plus mention of some other important cases, well known and not.)

Pharmaceutical companies sell products under the banner of science and medicine. However, their raison d’être is to make money. If industry gets involved in science, it has to balance genuine hypothesis testing and transparency against commercial interests, bureaucracy of drug regulation, and the financial consequences of dishonesty. This is not in itself a criticism – it is a simple fact.Universities exist for a different reason – to add to human knowledge and to disseminate that knowledge through publication and teaching. Subtle compromises have allowed the pharmaceutical industry to develop an extraordinary stranglehold over the scientific process, academic discourse, regulatory safeguards and common sense. It is hard to see how safeguards for dispassionate scientific discourse can be sustained when medicine flagrantly disregards them.
The pharmaceutical industry is accused of overturning the usual safeguards of science. The most fundamental of these safeguards is the accountability of authors. Readers of legitimate science expect that stated authors are truly the authors, that they vouch for the work, and that they would be able to defend their findings if challenged. They expect that authors have seen and scrutinized raw data, and would be able to provide that data if asked. That it is necessary to write this indicates how much we have lost.Industry has been inclined to use universities to give tainted science a veneer of respectability, while denying the very basis of that respectability. 'Ghost-writing' has been repeatedly criticized. However, professional 'medical writers' may sometimes have a legitimate role if clearly acknowledged. By emphasizing the 'writing' aspect, we divert attention from the far more important problem – that of 'ghost science,' of which 'ghost-writing' is only a part.

The usual definitions of scientific misconduct do not apply to pharmaceutical research. In February 2006, Gerald Schatten was accused of research misconduct. His crime was to have coauthored a stem-cell publication with the discredited Dr. Hwang Woo Suk, while shirking the 'responsibilities of verifying the data.' Schatten might have been irked to discover that at the same time, Procter and Gamble Pharmaceuticals (P&G) declared to the media that it was 'standard industry practice' to deny authors access to raw data in drug studies.

Blumsohn concludes:

The ethical challenge in pharmaceutical medicine is to use available data in the best possible way. Data are derived from human participants who subject themselves to risk in the public interest. They have the right to know that the data derived from their assumption of risk are used properly. When data are closed to scrutiny, even by the supposed authors of research, this cannot constitute an appropriate or ethical use of that data. Patients have to be involved in solving the problem.

Most importantly, as academics we need to reassert the importance of data and the
meaning of authorship. We also need to assert “old fashioned” ideas of academic
freedom, our right to speak the truth as we see it, and to allow that truth to be
subjected to open debate.

In the words of George Orwell (1984), 'Freedom is the freedom to say that two
plus two make four. If that is granted, all else follows.'

2 comments:

Anonymous
said...

Via today's BBC feed:

"Key information was absent from a research file prior to a London drug trial that left six men seriously ill, investigators have concluded. Drug research experts from the Netherlands say UK regulators did not receive findings that might have warned them of damage TGN1412 could do."

Six men have suffered and will have life long health issues because someone withheld information. Transparency at all levels of research, from funding to adverse test results, are necessary to protect the public.

This moves beyond financial gain and into the realm of protect the lives of those willing to sacrifice time and energy for the common good by participating in a trial. How many will now be deterred from trials due to this travesty? How much other data from other drugs has been "lost"?

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